CRS LogoCRS Header
Cal Rad Update
CT/Therapeutic Radiation Safety Bill Signed by the Governor
 
We have received a number of calls about the impact of recently signed SB 1237 (Padilla) on radiation safety. The bill has gotten some national attention and those descriptions of the provisions have not always relayed all the important facts. We have included below a summary of the major provisions and we encourage you to review this information.
 
In addition, we wanted to highlight a few things. First, though the bill was signed, all of its provisions have delayed effective dates. Thus the requirement to record dose information or report adverse events do not take effect until July 1, 2012. Second, the requirement for the CT study to record and make available DLP or CDTi vol dose information is only applicable that equipment that can record dose into the image system on a screen shot or protocol parameters page, i.e. there is no requirement to modify a CT scanner that does not have that capability or to replace equipment. The CRS will be providing additional information in the coming weeks.
 
This year SB 1237 (Padilla) was introduced and sponsored by the Consumer Attorneys of California with the intent to reduce the possibility of excessive radiation dose exposure. It was driven by recent stories of excess radiation exposure from CT scans at several California hospitals. The issue was also the subject of discussions and evolving policies by the FDA that may impact equipment manufacturers and users of CT scanners.
 
SB 1237 as introduced would have required that the dose for the ionizing radiation procedure be placed on the film. The CRS met with the author's staff and sponsors to better explain the current use of digital imaging and PACS systems on CT units. While it might be a laudable goal to make the effective radiation dose for a specific patient available, it was not practical, realistic or meaningful for patients.
 
SB 1237 continued to evolve as it progressed in the Legislature to also include provisions for reporting to BRH, the referring physicians and the patient when certain "misadministration" occurred. Those provisions were the subject of extensive discussions that also included the Ca. Bureau of Radiologic Health that suggested enhanced reporting requirements. Misadministration included repeating of a CT exam, providing a CT to the wrong patient or wrong anatomic area, and for radiation oncology exceeding the prescribed dose by 20%.
 
In the final analysis SB 1237 is not perfect, but the CRS was successful in achieving substantial amendments and a delayed operative date for all provisions until July 1, 2012. Our preference would have been to await the outcome of discussions on the national level, but it was clear that a bill was likely to pass.

SB 1237:
  1. Requires, commencing July 1, 2012, a person that uses a CT for human use to record the dose of radiation on every CT study produced during a CT examination.

  2. Requires the facility conducting the study to electronically send each CT study and  Protocol page, that lists the technical factors and dose of radiation, to the electronic picture archiving and communications system.

  3. Requires the displayed dose to be verified annually by a Medical physicist to ensure the displayed doses are within 20 percent of the true measured dose unless the facility is accredited.

  4. Requires the radiology report of a CT to include the dose of radiation by either recording the dose within the patient's radiology report or attaching the protocol page that includes the dose of radiation to the radiology report.

  5. Requires the provisions in this bill to be limited to CT systems capable of calculating and displaying the dose.

  6. Requires, for the purposes of this bill, that dose radiation be defined as one of the following:
    a) The computed tomography index volume and dose length product, as defined by the International Electrotechnical Commission and recognized by the Federal Food and Drug Administration; and, b) The dose unit as recommended by the American Association of Physicists in Medicine.

  7. Requires, commencing July 1, 2013, facilities that furnish CT to be accredited by an organization that is  approved by the federal Centers for Medicare and Medicaid Services, an accrediting agency approved by the Medical Board of California, or DPH.

  8. Requires a health facility, except for an event that results from patient movement or interference, to report  to DPH an event in which the administration of radiation results in any of the following:
  • Repeating of a CT examination, unless otherwise ordered by a physician or radiologist, if the following dose values are exceeded:
    • 0.05 Sv (5 rem) effective dose equivalent;
    • 0.5 Sv (50 rem) to an organ or tissue; or
    • 0.5 Sv (50 rem) shallow dose equivalent to the skin.

  • CT X-ray irradiation of a body part other than that Intended by the ordering physician or a radiologist if one of the following dose values are exceeded:
    • 0.05 Sv (5 rem) effective dose equivalent;
    • 0.5 Sv (50 rem) to an organ or tissue; or
    • 0.05 Sv (50 rem) shallow dose equivalent to the skin.

  • CT or therapeutic exposure that results in unanticipated permanent functional damage to an organ or a physiological system, hair loss, or erythema, as determined by a qualified physician;

  • A CT or therapeutic dose to an embryo or fetus that is greater than 50 msv (5 rem) dose equivalent, that is a result of radiation to a known pregnant individual unless the dose to the embryo or fetus was specifically approved, in advance, by a qualified physician;

  • Therapeutic ionizing irradiation of the wrong individual, or wrong treatment site; and,

  • The total dose from therapeutic ionizing radiation delivered differs from the prescribed dose by 20% or more. In a situation where the radiation was utilized for palliative care for the specific Patient the radiation oncologist need only notify the referring physician that the dose was exceeded.

    9.   Requires the facility, no later than five business days after discovery of an event described in 1) above,

   to Provide notification of the event to DPH and the referring physician of the person subject to the event.  

          Requires the facility, no later than 15 business days after discovery of an event described in #1 above, to  provide notification of the event to DPH and the referring physician of the person subject.



Please click here to view SB 1237.